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Use of markers in the diagnosis and treatment of lupus

a technology of lupus and markers, applied in the field of lupus diagnosis and treatment, can solve the problems of end-organ failure, multi-organ system damage, recognition and early treatment to prevent tissue and organ damage, and clinically challenging problems

Inactive Publication Date: 2020-06-18
BERG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The patent describes several biomarkers associated with Lupus, renal disease, scleroderma, and positive antinuclear antibody test results. These markers can be used to diagnose and treat these conditions, as well as to monitor the progression of the diseases. The patent also provides methods for using these markers to classify the stage or disease progression of Lupus in a subject. The biomarkers include AMP, S-adenosyl-L-homocysteine, glutarylcarnitine, N-acetyl-glutamine, pentacosanoylglycero-3-phosphate, coumaric acid, phe-pro, complement factor D, ficolin-2, and others.

Problems solved by technology

Local formation and / or deposition of circulating antigen antibody immune complexes trigger inflammatory responses that are responsible for a wide spectrum of systemic and organ-specific clinical presentations, characterized by remissions and exacerbations, leading to multi-organ system damage and, potentially, end-organ failure.
Given the heterogeneous nature of Lupus, recognition and early treatment to prevent tissue and organ damage is clinically challenging.
However, the traditional biomarkers incorporated in the SLEDAI are not necessarily the earliest or sufficient biologic signals of worsening disease.

Method used

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  • Use of markers in the diagnosis and treatment of lupus
  • Use of markers in the diagnosis and treatment of lupus
  • Use of markers in the diagnosis and treatment of lupus

Examples

Experimental program
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Effect test

example 1

Identification of Lupus Markers

[0510]Markers for Lupus were identified by methods described above. Table 1 provides a list of biomarkers identified in both serum and urine samples for Lupus. Expression levels of individual markers identified in Table 1 were analyzed in patients with Lupus and negative controls. FIGS. 7 and 8 are box plots depicting a direct comparison of normalized expression levels of individual markers identified between patients with Lupus and negative controls, i.e., patients without Lupus.

[0511]As shown in FIGS. 7 and 8, expression levels of AMP and S-adenosyl-L-homocysteine were increased in patients with Lupus when compared to negative controls. ROC curves were generated for these markers as well. As shown in FIG. 9 and Table 2, the combination of the two serum markers AMP and S-adenosyl-L-homocysteine has a predictive diagnostic value of 0.836 for patients with Lupus.

[0512]These data indicate that the markers identified in Tables 1 and 2 can be used as bioma...

example 2

Identification of Renal Disease Markers

[0513]Markers for renal disease were identified by methods described above. Tables 3 and 4 provide a list of biomarkers identified in serum and urine samples, respectively, from patients with renal disease.

[0514]Expression levels of individual markers identified in Tables 3 and 4 were analyzed in patients with renal disease and negative controls. ROC curves were generated for these markers as well. As shown in FIG. 10, a combination of two serum markers (glutarylcarnitine and N-acetyl-glutamine) has a predictive diagnositic value of 0.848 for patients with renal disease Similarly, a combination two urine markers (pentacosanoylglycine and ciliary neurotrophic factor receptor subunit alpha) has a predictive diagnostic value of 0.844 for patients with renal disease (FIG. 11).

[0515]These data indicate that the markers identified in Tables 3 and 4 can be used as biomarkers for the diagnosis and prognosis of renal disease, and to improve the accuracy...

example 3

Identification of Scleroderma Markers

[0516]Markers distinguishing scleroderma and Lupus were identified by methods described above. Tables 5 and 6 provide a list of biomarkers identified in serum and urine samples, respectively, from patients with scleroderma and patients with Lupus.

[0517]Expression levels of individual markers identified in Tables 5 and 6 were analyzed in patients with scleroderma and patients with Lupus. ROC curves were also generated for these markers. As shown in FIG. 12, a combination of five serum markers (2-furoylglycine, 3-methylphenylacetic acid, AMP, complement factor D, and ficolin-2) has a predictive diagnositic value of 0.831 for patients with scleroderma versus patients with Lupus. A combination of three urine markers (1,2-diacetyl-sn-glycero-3-phosphate, coumaric acid, phe-pro) has a predictive diagnostic value of 0.771 for patients with scleroderma verus patients with Lupus (FIG. 13).

[0518]In addition, two additional serum markers were identified to ...

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Abstract

Methods for diagnosing the presence of Lupus, renal disease, and scleroderma in a subject are provided, such methods including the detection of levels of markers diagnostic of Lupus, renal disease, and scleroderma, including proteins, nucleic acids, and lipids. The invention also provides methods of treating Lupus, renal disease, and scleroderma by modulating the level or activity of the marker proteins, nucleic acids and lipids. Compositions in the form of kits and panels of reagents for detecting the markers of the invention are also provided.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority to U.S. Provisional Application Ser. No. 62 / 750,041, filed on Oct. 24, 2018, the contents of which are incorporated herein by reference in their entirety.INCORPORATION BY REFERENCE[0002]All documents cited or referenced herein and all documents cited or referenced in the herein cited documents, together with any manufacturer's instructions, descriptions, product specifications, and product sheets for any products mentioned herein or in any document incorporated by reference herein, are hereby incorporated by reference, and may be employed in the practice of the invention.BACKGROUND[0003]Systemic Lupus erythematosus (SLE or Lupus) is characterized by the pathological formation of pathogenic autoantibodies against nuclear, cytoplasmic, and / or cell surface molecules, resulting from B and T cell immune dysregulation. Local formation and / or deposition of circulating antigen antibody immune complexes trigger inf...

Claims

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Application Information

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IPC IPC(8): C12Q1/6883
CPCG01N2800/104C12Q2600/158C12Q1/6883G01N33/6893
Inventor AKMAEV, VIATCHESLAV R.KIEBISH, MICHAEL ANDREWGRUND, ERIC
Owner BERG